A licence for manufacturing, import valid in perpetuity, say experts

FAQs: Decoding the Medical Devices Rules, 2017

Come January 1, 2018, there will be a radical shift in the legal regime applicable to medical devices. Under the current regime only 15 medical devices are covered for regulation under the Drugs and Cosmetics Rules, 1945. A gamut of 250 medical devices is proposed to be regulated under the Medical Devices Rules, 2017, which come into force in January. This list can be further expanded by notification from time to time. Damini Bhalla and Gargi Bohra share their insights into how the new regime will shape up. Edited excerpts:

Which devices come under the ambit of the Rules?

The Rules will be applicable to (i) substances used for in-vitro diagnosis and surgical equipment, such as surgical dressing, surgical bandage, etc.; (ii) mechanical contraceptives, disinfectants, and insecticides notified by the government; and (iii) devices notified by the government that are intended for internal or external use in diagnosing, treating, mitigating, or preventing any disease or disorder in human beings or animals. 
 

What is the basis for the classification of devices?

Under the Rules, medical devices have been classified into four classes: Class A (low risk); Class B (low moderate risk); Class C (high moderate risk); and Class D (high risk). Such classification is based on the intended use of the medical device and other scientific and technical parameters. The class-specific regulatory requirements specified in the Rules are required to be adhered to by manufacturers and importers.

What are the conditions for manufacturing licensing?

Applications for licences for manufacturing Class A or Class B medical devices have to be made to the state drugs controllers concerned. And those for manufacturing Class C or Class D medical devices or import licences for all classes of medical devices have to be made to the Drug Controller General of India (DCGI). Once granted, the licence for manufacturing and importing all classes of medical devices would remain valid in perpetuity. Manufacturers with existing licences or registration certificates have been provided some respite and their licences will remain valid till the original expiry date of such licence or for 18 months from the date of notification of these rules. 

What is the prescribed shelf life of the devices?

In a deviation from international standards, the shelf life of medical devices under the Rules is ordinarily presumed to be not more than five years from the date of manufacture. In case the manufacturer claims that the shelf life is longer than five years, evidence justifying this will have to be provided. The Rules also restrict the import of medical devices whose residual shelf life is below prescribed thresholds, which vary in accordance with the shelf life claim of the device. Separately, from January 1, 2022, a medical device would also have to bear a unique device identification, which would contain a device identifier and production identifier. 

Are there prescribed standards for the products?

All medical devices will have to conform to the standards laid down by the Bureau of Indian Standards or the health ministry. If no such standards are laid down, the device will have to conform to the standards laid down by the International Organisation for Standardisation or the International Electro Technical Commission. In case either of these standards is not specified, the device would have to conform to the validated manufacturer’s standard.

Medical device manufacturers will also have to follow the essential principles of safety and performance of medical devices specified in the guidelines issued by the health ministry. A draft of such guidelines was published in July 2017, inviting comments from stakeholders. 

Are there any provisions for auditing manufacturing sites?

The Rules include provisions for auditing of manufacturing sites. Once duly registered with the DCGI, they will be capable of carrying out audit of manufacturing sites of Class A and Class B medical devices. They may also be called upon to render assistance for regulating Class C and Class D medical devices. 

Damini Bhalla is a partner and Gargi Bohra is an associate at Luthra & Luthra Law Offices. 

(Views expressed are personal)